BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4091690 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26349
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 10/30/2014 WITH THE FOLLOWING FINDINGS: MOISTURE WAS PRESENT BEHIND THE DISPLAY LENS: THE REPORTED ISSUE WAS DUPLICATED. THE RETURNED BATTERY CAP WAS ABLE TO SECURE TO THE PUMP PER THE INSTRUCTIONS FOR USE (IFU). THE BATTERY COMPARTMENT WAS INTACT. THE PUMP CASE WAS OBSERVED TO BE CRACKED NEAR THE RIGHT SIDE OF THE DISPLAY LENS; THIS DEVICE FAILURE INDIRECTLY CAUSED THE REPORTED ISSUE. THE PUMP FAILED A LEAK TEST DUE TO THE PUMP CASE DAMAGE; THIS DEVICE FAILURE DIRECTLY CAUSED THE REPORTED ISSUE. THE FOLLOWING FINDINGS ARE RELATED TO THE REPORTED ISSUE: THE KEYPAD COVER WAS INTACT; HOWEVER, ALL OF THE KEYPAD BUTTONS WERE UNRESPONSIVE DUE TO INTERNAL MOISTURE DAMAGE. THE KEYPAD COVER WAS REMOVED, AND NO EVIDENCE OF CONTAMINATION WAS FOUND UNDER ANY OF THE KEY CONTACTS. THE PUMP CASE WAS REMOVED, AND EVIDENCE OF MOISTURE INGRESS WAS FOUND ON THE KEYPAD FLEX CABLE AND CONNECTOR, AS WELL AS OTHER INTERNAL COMPONENTS. UNRELATED TO THE REPORTED ISSUE, THE DISPLAY SCREEN VISUAL WAS DIM AND DISCOLORED DUE TO AN UNIDENTIFIED DISPLAY FAILURE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. REPORTEDLY, EVIDENCE OF MOISTURE INGRESS WAS OBSERVED BEHIND THE DISPLAY LENS; THERE WAS NO EVIDENCE SUGGESTING THAT THE PUMP SUSTAINED ANY PHYSICAL DAMAGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573013 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR